Apple and Huawei lead the explosion of the tens of billions of medical wearable devices market

Recently, Huawei's wrist ECG blood pressure recorder, Huawei WATCH D, is on sale.
The product is priced at 2,988 yuan, and the current sales volume is 6,000+
.

The device is a Class II medical device approved by the Food and Drug Administration on October 14, 2021, and is also Huawei's second Class II medical device product
.

It is suitable for adult wrist single-lead electrocardiogram (ECG) data acquisition (excluding automatic analysis and diagnosis functions), and measurement of adult blood pressure and pulse rate.

In addition, Huawei currently has 2 wearable products that have entered the green approval channel for medical devices
.

According to IDC (International Data Corporation) statistics, in 2020 and 2021, the global shipment of wearable devices will exceed 350 million units, and the domestic wearable device market will reach a quarter of the global market in 2020, and By 2025, the market size of this field is expected to increase to 46.
26 billion yuan
.

In this context, not only Huawei, but many technology giants have been certified and iteratively launched medical wearable devices this year.
While promoting mainstream functions such as electrocardiogram (ECG) and atrial fibrillation to a wider market, new Blood pressure and blood oxygen monitoring functions have also been launched; at the same time, small enterprises have also begun to make efforts in innovation in subdivisions
.

However, opportunities and challenges coexist.
At present, wearable devices still face many practical problems such as insufficient measurement accuracy, data not fully reaching the medical level, privacy protection, and incomplete policies
.

01 Led by giants, with domestic manufacturers as the fulcrum, the medical functions of wearable devices are enhanced

01 Led by giants, with domestic manufacturers as the fulcrum, the medical functions of wearable devices are enhanced

After nearly 4 years of development stagnation, wearable devices became a hot financing project in 2019, and the field also achieved a second "take-off"
.

According to IDC statistics, the shipment of wearable devices in the first quarter of that year reached 49.

Since then, manufacturers such as Apple, Samsung, Xiaomi (Huami), Huawei, BoAt and Fitbit have occupied the top five in the market for a long time
.

Global wearable device market in Q3 2021, source IDC official website

Even though the giants have never left the market during the nearly 20-year development of wearables, as Ramon T.
Llamas, research director of the wearables team at IDC, said, it is actually smaller companies that are driving the market growth
.

"Large companies have captured the attention of the global wearables market, but smaller companies have focused on specific markets and thrived with different solutions

Domestic small-scale enterprises such as Huagong Technology, Shengyi Technology, and Zhongjing Electronics have all invested heavily in the flexible circuit board business (one of the wearable device manufacturing materials); Goertek, the agent of Huawei Watch GT2 Pro ECG, has been recognized by the industry.
It is believed that it is also one of the OEMs of Apple AirPods, and won the NMPA registration certificate with ECG smart watches in 2020, completing its leap from consumer wearable products to medical wearable devices
.

Under such a "division of labor", smart wearable devices have ended the barbaric growth and ushered in the era of refined development, and the classification of devices has been further refined
.

In terms of device types, wrist-type consumer wearable devices dominated by smart watches have begun to occupy the main market
.

Taking the 2021 Q3 global wearable device shipments announced by IDC as an example, the quarterly shipments were 138 million units (+ 26.

The high-profile medical wearable devices attracted all kinds of participants
.

Especially in 2020, manufacturers of wrist wearable devices will extend from consumer-level functions to medical functions mainly based on electrocardiogram (ECG) monitoring

In 2020, Amazon, Google, OPPO, VIVO and other upstarts have entered the field one after another.
Amazon's Halo smart bracelet, OPPO and VIVO's smart watches are all from the consumption of sports health monitoring (heart rate, body fat, step counting, etc.
).
The latter two products have added medical functions on this basis
.

VIVO Watch supports all-weather heart rate monitoring and continuous blood oxygen saturation monitoring, while OPPO Watch ECG additionally has regular health monitoring functions such as heart rate monitoring, sleep monitoring, menstrual management, and sedentary reminders
.

It became the second and third smartwatches with ECG function in China after Huawei at that time

Functional innovations also revolve around ECG
.

"Wenxin Xiaoyi", a domestic innovative enterprise Wenxin Electronic Technology, obtained the NMPA Class II medical device certification in September of that year.

In addition to technology giants, the entry of traditional machinery companies has also enhanced the medical functions of smart wearable devices
.

In the field of smartwatches, the approved products include Lexin Medical's H1, Jinyidi Medical's blood pressure watch and Yunxiang Medical's smart watch

Lexin Medical is a medical device company focusing on smart wearables and vital signs monitoring products.
Its health watch H1 passed the second-class medical device registration in December 2019, and is the first medical-grade ECG monitoring smart watch
.
In the first quarter of 2020, shipments increased by 72.
9%, entering the top 5 shipments in the domestic wearable market for the first time
.

Founded in 2005, Jinyidi Medical has obtained NMPA certification for 16 wearable electronic sphygmomanometers in 2020.
Among them, Jinyidi blood pressure watch is the only medical device in the world that has passed the medical device registration of the State Food and Drug Administration and the EU medical device.
Certified, US medical device certified blood pressure watch
.

Entering 2021, Huawei, Apple, Samsung and other giants iteratively launched a variety of wrist wearable devices.
In addition to the mainstream ECG monitoring functions, data collection and detection functions such as blood sugar, blood pressure, and atrial fibrillation have been added
.

In June and September 2021, Apple's mobile ECG prompt software and another mobile pulse rate atrial fibrillation prompt software respectively obtained the NMPA Class II registration certificate
.

Apple atrial fibrillation reminder software approved by the Food and Drug Administration

Samsung released the Galaxy Watch4 in August.
In addition to the electrocardiogram (ECG) function, it also has health functions such as atrial fibrillation detection, blood oxygen and blood pressure monitoring
.

As a result, the domestic market is also thoroughly booming
.
According to IDC data, by 2023, China's wearable device market shipments will approach 200 million units
.

In terms of approval, according to incomplete statistics from Shell, as of the end of 2021, the Food and Drug Administration has at least 41 medical wearable products that have obtained the second-class registration certificate for medical devices, of which 85% were approved in 2019 and later, and half were approved.
The above products come from domestic manufacturers such as Goertek, Shenzhen Jinyidi and Soth Suzhou
.

It is foreseeable that with the in-depth association of popular tracks such as Internet medical care and digital therapy with wearable devices, wearable devices will tend to deepen medical functions in the future
.

The industry believes that next-generation physiological signal detection represented by blood pressure and blood sugar will become an important feature of wearable devices
.

02 Blood pressure and blood sugar detection will become important features of wearable devices

02 Blood pressure and blood sugar detection will become important features of wearable devices

In recent years, the market prospects of chronic diseases have been verified
.
According to the "2021 World Health Report" released by WHO, chronic diseases such as cancer, cardiovascular disease, diabetes, and chronic respiratory disease have become the main causes of premature human death
.

The number of deaths caused by the four major chronic diseases in the world reached 33.
2 million in 2019, and the prevalence rate is even higher
.
Data show that in the same year, the number of people with hypertension in China alone has exceeded 300 million, and the number of diabetic patients has also exceeded 100 million
.

This has driven the continuous improvement of the chronic disease diagnosis and treatment system, and wearable device developers have also sensed opportunities, extending from the field of electrocardiography (ECG) to blood pressure and blood sugar monitoring
.

The field of blood pressure monitoring will be led by leading brands such as Samsung, Huami, and Huawei in 2021
.
The Huawei Watch D and Samsung Galaxy Watch 4 mentioned above are representative products
.
Among them, Huami's blood pressure monitoring software, which was approved later than Huawei, and Samsung's blood pressure monitoring software, which has not yet entered the domestic market, all require the calibration of traditional blood pressure monitors
.

Huami released the PumpBeats blood pressure monitoring engine and BioTracker 3.
0 PPG sensor in July 2021; with these two technologies, users can measure blood pressure with wearable devices anytime, anywhere, and the whole process only takes 30 seconds to press
.

On November 22, Huami announced that the Amazfit Yuewo GTR3 Pro equipped with this technology combination officially launched the blood pressure screening function, becoming one of the first smart watches in China to use photoelectric sensors to measure blood pressure on the wrist
.
At present, its price is 899 yuan, which is considered to be the most cost-effective smart watch in the industry
.

One of the highlights of the Galaxy Watch4 is the new three-in-one sensor that integrates three health sensors in a single chip - an optical heart rate sensor, an ECG sensor, and a bioelectrical impedance analysis sensor for blood pressure measurement
.
However, users are still required to calibrate the device every four weeks using a traditional cuff blood pressure monitor that is certified as a medical device
.

The wearable device field involving blood sugar monitoring may be dominated by Apple
.
In July 2021, one of Apple's sensor suppliers, Rockley Photonics, a silicon photonic chip and module supplier, announced that it will soon develop a non-invasive blood glucose monitoring sensor
.
As a result, Apple's next-generation Apple Watch products are expected to have the function of blood sugar monitoring
.

However, as an integrated software and hardware product, wearable devices involve many technical fields, including human-computer interaction technology, sensor technology (converting non-electrical signals into electrical signals), flexible electronic technology (direct contact with the human body), battery technology,
etc.

This has led to slower development of monitoring functions such as blood pressure and blood sugar than that of electrocardiogram (ECG) monitoring.
At the same time, from the current point of view, the commercial application of the aforementioned two functions will take some time
.

03The data accuracy and privacy protection capabilities of medical-grade wearable devices are yet to be verified

03The data accuracy and privacy protection capabilities of medical-grade wearable devices are yet to be verified

Sensor is one of the key components affecting wearable devices, and it is also the difficulty in improving device performance
.

Blood pressure measurement is performed using photoelectric sensors, which not only need to monitor pulse wave frequency, but also waveform information
.
However, when the optical sensor measures pulse waves, it will be affected by factors such as the environment, skin color (currently, this function of Huami does not support people with black skin), hair and other factors.
Therefore, when the sensor degrades the collected waveform information to eliminate interference When the data reliability is reduced, the accuracy is naturally not guaranteed
.

The technical bottleneck of non-invasive blood glucose monitoring and detection has not been broken through
.
At present, the spectral characteristics of glucose molecules (most obvious in the near-infrared and mid-infrared) are mainly used, but this is also the difficulty
.
Near-infrared and mid-infrared light cannot penetrate most human tissues, so the photoelectric sensors used often need to overcome issues such as power efficiency, signal strength, spectral coverage, and resolution
.

The accuracy of the more mainstream ECG monitoring data is also questioned
.
Professor Pan Wenzhi of the Department of Cardiology, Zhongshan Hospital Affiliated to Fudan University once publicly stated, "The market potential of wearable ECG detection devices is huge, but because wearable detection devices such as wristbands detect the pulse rather than the chest, there may be some problems.
Errors require continuous improvement of precision in technology in the future
.
”

At the same time, challenges in data privacy protection still exist, and data security has also become a restrictive factor hindering the development of wearable medical devices
.
Wearable medical equipment is a device that monitors health data in real time close to the human body.
The monitored data includes a large number of user health, geographic location information and other private information, and information collection is not limited by time and place
.
Therefore, once user privacy is attacked by hackers, life and health may be threatened
.

But according to a senior analyst in the digital health market, the more important question now is how the data will be clinically recognized and used
.
Because in fact, some of the current functions of wearable devices such as blood pressure, blood lipids, and blood sugar detection lack effective medical professional resource support, and their clinical value is not high.
They cannot perform medical functions, and they cannot be recognized by patients
.

summary

summary

Opportunities and challenges coexist, which is the most accurate description of the domestic medical wearable device market
.
The increase of technology giants such as Huawei, Xiaomi, and Apple has made this market continue to attract attention
.

At the same time, although the equipment still faces various technical problems such as insufficient measurement accuracy, not fully reaching the medical level, and privacy protection
.
However, backed by the domestic medical market that does not lack data, driven by technology giants with commercialization strength, innovative start-up companies and traditional medical equipment manufacturers with technical strength, the prospect of medical wearable devices is very promising
.

In the future, there is still huge room for imagination in the new segments of wearable devices such as smart clothing and smart glasses
.

References:

References:

Arterial Network, "Apple's next medical device, non-invasive blood sugar will become a new outlet", "Amazon, Google admission, NMPA approval record, wearable continues to be popular2020 annual inventory"

Arterial Network, "Apple's next medical device, non-invasive blood sugar will become a new outlet", "Amazon, Google admission, NMPA approval record, wearable continues to be popular2020 annual inventory"

Health Industry, "2021 China Smart Wearable Device Industry Research Report"

Health Industry, "2021 China Smart Wearable Device Industry Research Report"

Oriental Fortune.
com, "Foreseeing 2021: Panorama of the wearable device industry in 2021 (with competitive landscape, market size, development trends, etc.
)"

Oriental Fortune.
com, "Foreseeing 2021: Panorama of the wearable device industry in 2021 (with competitive landscape, market size, development trends, etc.
)"